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St. Jude Medical (STJ) Heartmate 3 LVAS Demonstrated Improved Clinical Outcomes For Patients Suffering From Advanced Heart Failure



11/16/2016 10:39:36 AM

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  • MOMENTUM 3 Study meets primary endpoint for short-term indication
  • Results presented during late-breaking clinical trial session at the AHA Scientific Sessions
  • MOMENTUM 3 Study data published in the New England Journal of Medicine

ST. PAUL, Minn. & NEW ORLEANS--(BUSINESS WIRE)--St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced results of the MOMENTUM 3 U.S. IDE Clinical Study during a late-breaking clinical trial session at the American Heart Association (AHA) Scientific Sessions in New Orleans. The MOMENTUM 3 study compared the HeartMate 3 Left Ventricular Assist System (LVAS) to the HeartMate II LVAS in treating advanced stage heart failure and is the largest LVAD trial in the world to evaluate both short-term and long-term patients in a single study. The study results demonstrated patients receiving the HeartMate 3 LVAS had an 86.2 percent survival rate with freedom from disabling stroke and reoperation to repair or replace the device.

“These data in the MOMENTUM 3 study represent the continued advancement in therapy options available for patients living with debilitating heart failure”

The MOMENTUM 3 IDE study is a prospective, multi-center, randomized, unblinded, study evaluating the safety and effectiveness of the HeartMate 3 LVAS when used for the treatment of advanced, refractory, left ventricular heart failure. More than 1,000 patients with New York Heart Association (NYHA) Class IIIB or IV heart failure are participating in the study. Patients are being followed for a short-term endpoint of six months, and a long-term endpoint of two years. Current data show the results at the six-month follow-up in the first 294 patients enrolled.

The primary endpoint for the study was six months survival with freedom from disabling stroke and reoperation to repair or replace the device. The study met its primary endpoint (non-inferiority P<0.0001; superiority P=0.037). There were no pump thrombosis events reported in patients who were implanted with HeartMate 3 LVAS at six months, confirming the results observed with the HeartMate 3 LVAS in the CE Mark trial. Rates of all other adverse events were similar between the HeartMate 3 LVAS and historical rates seen in the HeartMate II LVAS, which is the most widely used and extensively studied LVAD commercially available. This study included all-comers, which means researchers evaluated the device regardless of whether the patient needed a short-term support option while awaiting transplantation or a long-term support option for those who are not candidates for cardiac transplantation.

“The Heartmate 3 LVAS improved clinical outcomes in the MOMENTUM 3 study by avoiding the need for surgical reoperation to replace or remove the pump due to pump thrombosis,” said Dr. Mandeep R. Mehra, medical director of Brigham and Women’s Hospital Heart and Vascular Center in Boston. “More importantly, these clinical gains occurred without an increase in other adverse events, providing important therapeutic progress for our advanced heart failure patients.”

The HeartMate 3 LVAS is a small, implantable mechanical circulatory support (MCS) device for advanced heart failure patients who are awaiting transplantation or are not candidates for heart transplantation. It is the first commercially approved (CE marked) LVAD with Full MagLev technology, designed to minimize complications and restore blood flow. The HeartMate 3 system utilizes Full MagLev technology, which allows the device’s rotor to be “suspended” by magnetic forces. This design aims to reduce trauma to blood passing through the pump and improve outcomes for patients.

“These data in the MOMENTUM 3 study represent the continued advancement in therapy options available for patients living with debilitating heart failure,” said Dr. John B. O’Connell, vice president and medical director for mechanical circulatory support at St. Jude Medical. “The HeartMate II LVAS is an extremely important medical advancement with more than 24,000 implants having occurred to date, and it is the only LVAD approved for both Bridge-to-Transplant and Destination Therapy options in the U.S. The data, now being seen with the HeartMate 3 LVAS, show that we are taking the next steps in advancing medical therapy options.”

Study Oversight Committee includes:

  • Dr. Mandeep R. Mehra (Chair, Publication and Presentation Committee), Brigham and Women’s Hospital, Boston, MA
  • Dr. Joseph Cleveland, University of Colorado, Denver, CO
  • Dr. Daniel Goldstein, Montefiore Medical Center, NY, NY
  • Dr. Nir Uriel, University of Chicago, Chicago, IL

The HeartMate 3 LVAS is CE Mark approved and limited by federal law to investigational use in the United States.

About Heart Failure

Heart failure is a widespread, chronic condition that develops when the heart muscle weakens and is unable to pump a sufficient amount of blood throughout the body. Heart failure worsens over time and is typically caused by persistent high blood pressure, heart attack, valve disease and other forms of heart disease or birth defects. Left untreated, the lack of adequate blood flow causes the organs to progressively fail, resulting in numerous medical complications that deteriorate a person’s quality of life.

According to the American Heart Association (AHA) and the Heart Failure Society of American (HFSA), about 6 million Americans are living with heart failure today, and 670,000 new cases are diagnosed each year. In the United States, the number of deaths from this condition has more than doubled since 1979.1

About the HeartMate 3 Left Ventricular Assist System

The HeartMate 3 LVAS includes a centrifugal blood pump that is implanted directly onto a patient's native heart and designed to supplement the pumping ability of the weakened heart's left ventricle, which is responsible for pumping oxygen-rich blood from the lungs throughout the body. The device is implanted above the diaphragm, immediately next to the native heart, and is attached to the aorta (the main artery that feeds blood into the entire body), leaving natural circulation in place while providing all of the energy necessary to propel blood throughout the body. The patient wears an external, wearable controller and battery system that powers the pump. The HeartMate 3 LVAS can pump up to 10 liters of blood per minute.

About St. Jude Medical’s Heart Failure Business

St. Jude Medical is pioneering heart failure disease management with innovative solutions like the CardioMEMS HF System, ground-breaking quadripolar technology and, in select European markets, the HeartMate 3 left ventricular assist system and our first-to-market MultiPoint Pacing technology.

St. Jude Medical collaborates with heart failure specialists, clinicians and advocacy partners to provide a comprehensive product portfolio that includes innovative, cost-effective solutions that help reduce hospitalizations and improve patient quality of life for heart failure patients around the world.

For more information about St. Jude Medical’s focus on heart failure, visit the St. Jude Medical Heart Failure Media Kit or the St. Jude Medical PULSE Blog.

Information for patients to learn more about heart failure can be found at www.heartfailureanswers.com.

About St. Jude Medical

St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world's most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world.

Headquartered in St. Paul, Minn., St. Jude Medical employs approximately 18,000 people worldwide and has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management and cardiovascular. For more information, please visit sjm.com or follow us on Twitter @SJM_Media.

Forward-Looking Statements

This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that involve risks and uncertainties. Such forward-looking statements include the expectations, plans and prospects for the company, including potential clinical successes, reimbursement strategies, anticipated regulatory approvals and future product launches, and projected revenues, margins, earnings and market shares. The statements made by the company are based upon management’s current expectations and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include market conditions and other factors beyond the company’s control and the risk factors and other cautionary statements described in the company’s filings with the SEC, including those described in the Risk Factors and Cautionary Statements sections of the company’s Annual Report on Form 10-K for the fiscal year ended January 2, 2016 and Quarterly Report on Form 10-Q for the fiscal quarter ended October 1, 2016. The company does not intend to update these statements and undertakes no duty to any person to provide any such update under any circumstance.

Contacts

St. Jude Medical, Inc.
J.C. Weigelt, 651-756-4347
Investor Relations
jweigelt@sjm.com
or
Kristi Warner, 651-756-2085
Media Relations
kwarner@sjm.com


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